Proof-of-concept Study for SAR441344 (Frexalimab) in Relapsing Multiple Sclerosis

Phase 2

Active, not recruiting

Conditions: Multiple Sclerosis

Interventions: Drug: placebo IV
Drug: SAR441344 IV
Drug: placebo SC
Drug: SAR441344 SC
Drug: MRI contrast-enhancing preparations

Registration Number: NCT04879628

Lead Sponsor: Sanofi

Brief Summary: Primary Objective:

To determine the efficacy of SAR441344 as measured by reduction of the number of new active brain lesions

Secondary Objective:

* To evaluate efficacy of SAR441344 on disease activity as assessed by other MRI measures

* To evaluate the safety and tolerability of SAR441344

* To evaluate pharmacokinetics of SAR441344

Detailed Description: The duration of each participant will be no longer than 320weeks in both parts of the study, including 4 weeks of screening, at maximum 292 weeks of treatment and 24 weeks of follow-up.

Recruitment & Eligibility

Status: ACTIVE_NOT_RECRUITING

Sex: All

Target Recruitment: 129

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Intravenous (IV) SAR441344	MRI contrast-enhancing preparations	SAR441344 IV
IV Placebo	placebo IV	Placebo IV
IV Placebo	MRI contrast-enhancing preparations	Placebo IV
Intravenous (IV) SAR441344	SAR441344 IV	SAR441344 IV
SC Placebo	placebo SC	Placebo SC
SC Placebo	MRI contrast-enhancing preparations	Placebo SC
Subcutaneous (SC) SAR441344	SAR441344 SC	SAR441344 SC
Subcutaneous (SC) SAR441344	MRI contrast-enhancing preparations	SAR441344 SC

Primary Outcome Measures

Name	Time	Method
Mean Number of New Gadolinium (Gd)-Enhancing T1--Hyperintense (GdE T1) Lesions at Week 12 Relative to Week 8 as Measured by Brain Magnetic Resonance Imaging (MRI)	Week 8 and Week 12	Cranial (brain) MRI was performed to identify number of new GdE T1-hyperintense lesions at Week 12 relative to Week 8 MRI. Central review was used to identify new GdE T1 lesions not present at the previous MRI scans.

Secondary Outcome Measures

Name	Time	Method
Maximum Plasma Concentration (Cmax) of SAR441344	After dose on Day 1 (first dose) and Weeks 8 (IV arm) and 10 (SC arm) (last dose)	Blood samples were collected at the specified timepoints for the assessment of Cmax. Cmax was assessed by a Bayesian approach using the population pharmacokinetic (PK) model.
Mean Number of New or Enlarging T2 Lesions at Week 12 Relative to Week 8	Week 8 and Week 12	Cranial (brain) MRI was performed to identify number of new or enlarging T2 lesions at Week 12 relative to Week 8.
Mean Total Number of GdE T1 Lesions at Week 12	Baseline (Day 1) and Week 12	Cranial (brain) MRI was performed to identify total number of GdE T1 lesions at Week 12.
Double-Blind Period: Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Treatment-Emergent Serious Adverse Events (TESAEs)	From first dose of study drug (Day 1) up to 12 weeks (DB TE period)	An AE was any untoward medical occurrence in a participant or clinical study participant, temporally associated with the use of study drug, whether or not considered related to the study drug. An SAE was any untoward medical occurrence that, at any dose: resulted in death, was life-threatening, required inpatient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity, was a congenital anomaly/birth defect or was an important medical event. TEAEs were defined as AEs that developed, worsened or became serious during the TE period.
Double-Blind Period: Number of Participant With Anti-Drug Antibodies (ADAs) Against SAR441344	From first dose of study drug (Day 1) up to 12 weeks (DB TE period)	Blood samples were collected at specified timepoints to assess the presence of ADAs against SAR441344. Treatment-emergent ADA was defined as at least 1 treatment-induced/boosted ADA. Treatment-induced ADA was defined as ADA that developed during the TE period and without pre-existing ADA (including participants without pre-treatment samples). Treatment-boosted ADA was defined as pre-existing ADA that was boosted during the TE period to a significant higher titer than the baseline. Number of participants with treatment-emergent ADA are presented.
Time to Maximum Plasma Concentration (Tmax) of SAR441344	After dose on Day 1 (first dose) and Weeks 8 (IV arm) and 10 (SC arm) (last dose)	Blood samples were collected at the specified timepoints for the assessment of tmax. tmax was assessed by a Bayesian approach using the population PK model.
Area Under the Curve Over the Dosing Interval (AUC0-tau) of SAR441344	After dose on Day 1 (first dose) and Weeks 8 (IV arm) and 10 (SC arm) (last dose)	Blood samples were collected at the specified timepoints for the assessment of AUC0-tau. AUC0-tau was assessed by a Bayesian approach using the population PK model.

Trial Locations

Locations (37): Center for Neurology and Spine- Site Number : 8400007
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Phoenix, Arizona, United States
Medical College of Wisconsin- Site Number : 8400006
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Milwaukee, Wisconsin, United States
University of South Florida Site Number : 8400001
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Tampa, Florida, United States
The Neurological Institute Site Number : 8400004
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Charlotte, North Carolina, United States
Investigational Site Number : 1000002
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Pleven, Bulgaria
Investigational Site Number : 1000003
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Sofia, Bulgaria
Investigational Site Number : 1000001
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Sofia, Bulgaria
Investigational Site Number : 1240001
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Gatineau, Quebec, Canada
Investigational Site Number : 2030003
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Brno, Czechia
Investigational Site Number : 2030002
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Hradec Králové, Czechia
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Center for Neurology and Spine- Site Number : 8400007
🇺🇸Phoenix, Arizona, United States